Senior Regulatory Affairs Specialist

Job Summary

Supporting global clinical submissions, the full-time remote Senior Regulatory Affairs Specialist will manage the planning, authorship, and delivery of regulatory dossiers while collaborating with cross-functional teams to ensure compliance and strategic alignment.

Key responsibilities

• Lead the assembly of regulatory dossiers and support the planning and execution of major clinical regulatory submissions
• Collaborate with clinical program teams to integrate regulatory considerations into trial processes and support inspection readiness
• Contribute to the development and lifecycle management of global core clinical dossiers, ensuring adherence to local regulations and standards

Required qualifications

• Bachelor's degree in life sciences or a related field
• 8 years of experience in biotech/pharma, with at least 4 years in Regulatory Affairs for drugs or medical devices
• Demonstrated knowledge of global IND/CTA submissions and regulatory interactions
• Basic understanding of ICH GCP and global clinical trial regulations
• Strong computer skills in Word, Excel, and Adobe Acrobat, with experience in electronic publishing/file management systems